Abstract
REALI pooled database, encompassing Gla-300 studies conducted in different European countries, is a platform to identify factors contributing to glycemic control in patients with uncontrolled T2DM initiated on Gla-300. A stepwise multivariable regression analysis was performed on selected demographic and baseline characteristics associated with HbA1c drop ≥ 0.5% after 6 months of Gla-300 treatment from 8 studies (3 interventional and 5 observational). The criterion for retention in the model was p ≤ 0.05. From the 2624 subjects included, 64.2% have dropped their HbA1c level by at least 0.5%, 56% were male and 37% were insulin naïve. Means ± SD were 64 ± 9.4 years for age and 32.2 ± 5.4 kg/m2 for BMI. Mean ± SD baseline HbA1c was 8.5 ± 1% and 0.29 ± 0.18 U/kg/day for Gla-300 starting dose. Multivariable analyses identified baseline HbA1c as the major predictive factor associated with HbA1c reduction, with a nonlinear relationship, and odds were higher in the highest baseline HbA1c value (p < 0.0001). Lower BMI (p = 0.048), shorter duration of diabetes (p = 0.016), being insulin naïve (p < 0.0001), and lower Gla-300 starting dose (p < 0.001) have also been identified as potential predictors of HbA1c improvement. These results can help clinicians to identify T2DM patients who are likely to benefit most from Gla-300 treatment. Disclosure G. Bigot: None. M. Bonnemaire: Employee; Self; Sanofi. R.C. Bonadonna: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Sanofi-Aventis. Speaker's Bureau; Self; Eli Lilly and Company, Sanofi-Aventis. P. Gourdy: Advisory Panel; Self; AstraZeneca. Board Member; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis, Servier. Speaker's Bureau; Self; Abbott, Amgen Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis, Servier. D. Müller-Wieland: Advisory Panel; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. D. Mauricio: Advisory Panel; Self; Merck Sharp & Dohme Corp., Sanofi. Speaker's Bureau; Self; Almirall, S.A., Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Urgo Medical. A. Ciocca: Employee; Self; Sanofi. N. Freemantle: Advisory Panel; Self; Sanofi. Research Support; Self; Akcea Therapeutics, Allergan, AstraZeneca, Ipsen Biopharmaceuticals, Inc., Sanofi, Takeda Pharmaceutical Company Limited. Speaker's Bureau; Self; Sanofi. Funding Sanofi
Published Version
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